Brexit-related guidance for companies

Table of contents

The European Medicines Agency (EMA) and the European Commission are providing guidance to help pharmaceutical companies responsible for both human and veterinary medicines prepare for the United Kingdom's (UK) withdrawal from the European Union (EU), a process known as 'Brexit'.

This aims to ensure that companies are ready to take the necessary steps to enable undisrupted supply of their medicines in the EU for the benefit of patients, based on the assumption that the UK will become a third country as of 30 March 2019.

Guidance on centrally authorised products

Companies should check this page regularly for guidance on the consequences of Brexit, as EMA and the European Commission are preparing a series of guidance documents.

Change of format for pre-submission meetings

For human and veterinary initial marketing authorisation applications, EMA will hold all pre-submission meetings requested as of 1 October 2018 remotely, either via teleconference or virtual meeting, until the Agency is fully operational in its new permanent premises at the end of 2019.

Industry survey (for centrally authorised products)

EMA carried out a Brexit-preparedness survey in 2018, to gather information from marketing authorisation holders on their preparedness for Brexit.

The main aim was to to obtain information on the timelines for submission of necessary regulatory changes, and identify any centrally authorised products at potential risk of supply shortages. EMA published a high-level summary of the results in July 2018:

Based on the survey results, EMA was concerned about potential supply shortages for 108 medicines (88 human and 20 veterinary). EMA contacted the marketing authorisation holders between July and September 2018 and received reassurance on the regulatory planning for a significant proportion.

Update: In October 2018, EMA revised the number down to 31 centrally authorised products (19 human medicines and 12 veterinary medicines) for which it remained concerned about potential Brexit-related supply disruptions.

EMA, together with its scientific committees, has assessed how critical these products are for the treatment of the disease they target. National competent authorities will check whether there are possible therapeutic alternatives available in their country.

The number of medicines considered to be at risk are subject to change based on updates provided by the marketing authorisation holders. EMA continues working with them directly to address any outstanding issues.

According to EU law, the marketing authorisation holder, QPPV, PSMF and certain manufacturing sites need to be based in the European Economic Area (EEA) for a company to be able to market a medicine in the EU.

Stakeholder meetings

EMA has published reports with updates from the Agency and EU industry associations on their preparations for Brexit and information on planned stakeholder engagement activities from the Agency's meetings with industry stakeholders: